In November 2023, NMPA approved 301 medical devices, including 34 Class III imported products, 39 Class II imported products, and 226 Class III domestic products.
China NMPA is constantly upgrading regulations and guidelines for medical device regulatory, clinical affairs and post market surveillance in latest years. BradyKnows elite team has extensive experiences to support the whole life cycle of medical device. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Below is a list of approved Class III and Class II imported products in November 2023.
Medical Device/IVD
Manufacturer
Category
Proton Therapy System
Varian Medical Systems Particle Therapy GmbH & Co. KG
Class III
Amplatzer Talisman PFO Occluder
Abbott Medical
Class III
Amplatzer Talisman Delivery Sheath
Abbott Medical
Class III
CONTACT LENSES
Supervision Optimax Sdn Bhd
Class III
Arctic Sperm Cryopreservation Medium
FUJIFILM Irvine Scientific, Inc.
Class III
Anchored balloon dilatation catheter
株式会社カネカ
Class III
Dual-curing bonding resin watermend
Tokuyama Dental Corporation
Class III
SU-POR Patient-Specific Surgical Implant
Poriferous, LLC
Class III
Sterile Silicone Breast Implants Motiva Implant Matrix
Establishment Labs S.A.
Class III
ProTi360°Interbody System
Tyber Medical, LLC
Class III
MP Monoblock Hip Prosthesis Stem
Waldemar Link GmbH & Co. KG
Class III
ROTAPRO Rotational Atherectomy System
Boston Scientific Corporation
Class III
Diagnostic Ultrasound System
GE Healthcare Austria GmbH & Co OG
Class III
ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
Boston Scientific Corporation
Class III
SPECT/CT
Spectrum Dynamics Medical Ltd.
Class III
Precision1 for Astigmatism soft contact lenses
Alcon Laboratories, Inc.
Class III
Clareon PanOptix Trifocal Hydrophobic IOL
Alcon Laboratories, Incorporated
Class III
Continuous Single Culture® Complete (CSCM-C)
FUJIFILM Irvine Scientific, Inc.
Class III
Soft Tissue Implants Visco-elastic gel of hyaluronic acid – with lidocaine
